FDA reissues sex-specific data guidance after sanitizing anything considered DEI-related

As part of President Donald Trump’s directive to eliminate anything construed as related to diversity, equity and inclusion (DEI), the US Food and Drug Administration (FDA) has revised a decade-old guidance on using sex-specific data in medical device clinical studies. The reissued guidance also eschews a modernized version of the guidance proposed in the final weeks of the Biden Administration.

Immediately upon taking office in January, Trump signed an executive order to remove any DEI initiatives, programs, or in some cases even mentions of gender, race, or diversity from federal documents or programs. This led to the removal of FDA’s clinical trial diversity action plans draft guidance and portions of FDA’s website that were construed as being related to DEI. (RELATED: Experts: Trump executive orders create foundation for what’s to come, Regulatory Focus 24 January 2025)

The diversity action plan guidance, which FDA is required by law to issue under the Food and Drug Omnibus Reform Act (FDORA) of 2022, has since been restored due to a court order, with the following disclaimer:

“Any information on this page promoting gender ideology is extremely inaccurate and disconnected from the immutable biological reality that there are two sexes, male and female. The Trump Administration rejects gender ideology and condemns the harms it causes to children, by promoting their chemical and surgical mutilation, and to women, by depriving them of their dignity, safety, well-being, and opportunities. This page does not reflect biological reality and therefore the Administration and this Department reject it.”

In the final weeks of the Biden Administration, FDA proposed modernizing two guidances related to the study sex differences in the clinical evaluation of medical products and sex- and gender-specific data from clinical studies for medical devices. However, on 31 March, it reissued the guidance on sex-specific data to remove all mentions of gender, gender identity, gender expression, transgender, nonbinary, and intersex that had been added to the Biden-era document and removed some references to gender and other factors from the 2014 version. (RELATED: FDA proposes to modernize guidance on sex, gender in clinical trials, Regulatory Focus 14 January 2025)

For instance, the version issued in January 2025, before Trump took office, noted that “sex is generally assigned based on anatomy at birth and is usually categorized as female or male, but variations occur. Variations of sex refers to differences in sex development (DSD) or intersex traits,” and clarified that gender “is a multidimensional construct that encompasses how an individual self-identifies. Gender may be described across a continuum, may be nonbinary, and may change over the course of a lifetime. Gender may or may not correspond to a person’s sex assigned at birth.”

Additionally, the guidance stated that study sponsors may wish to include an intersex category to account for individuals with atypical chromosomal, gonadal, or anatomic sex, and provided an example of how gender-based differences can be relevant to the clinical study of a device intended for single-sex populations.

“The impact of sex and/or gender may be more relevant to certain types of products or diseases than others. For example, certain obstetrical, gynecologic and urologic devices may be intended for use in single-sex populations, so clinical studies of these devices would not be expected to address the potential for sex-specific outcomes. Even for these devices, however, there may be important gender-based differences that should be considered, such as device performance in transgender men who choose to retain their uterus/ovaries (e.g., to maintain the option of pregnancy),” the Biden-era guidance stated.

The 2014 version of the document also states that sex is not the only factor that may affect a medical device's performance. It notes that while the guidance focuses on sex, its recommendations may also promote trial enrollment and data analysis that accounts for other demographic variables, including age, race, and ethnicity. The new version, however, has removed that entire section from the guidance.

The 2014 version also addressed questions regarding gender and tried to clarify FDA’s understanding of the difference between sex and gender.

“The terms sex and gender are often used interchangeably in the scientific literature and popular press,” said the guidance. “However, according to a 2001 consensus report from the Institute of Medicine, the terms have distinct definitions which should be used consistently to describe research results.”

“The differences of greatest interest to FDA are those associated with biological factors (sex); however most medical device studies rely on patient self-reported values (gender),” the older version of the guidance added. “For the purposes of this guidance document we use the term sex, with the understanding that for most medical device studies gender is used as a surrogate for sex.”

The newly-issued guidance, however, removes that clarification between sex and gender and any references to gender. It also now only mentions race in its footnotes.

The new guidance removed footnotes referencing stakeholder comments, research information, and other considerations. It deleted a footnote on potentially unique considerations for participants who are part of the lesbian, gay, bisexual, transgender and queer (LGBTQ) community, intersex and gender non-conforming (GNC) individuals. FDA has previously clarified that such considerations were outside the scope of the guidance.

In another instance, it deleted a footnote referencing the Office of Research on Women’s Health at the National Institutes of Health (NIH), which has resources for recruiting and retaining women in clinical trials.

The updated guidance also removed the word diverse from the phrase “diverse populations” in the guidance as part of its targeting of words considered part of DEI.

2014 guidance, January 2025 guidance, March 2025 guidance

FDA reissues sex-specific data guidance after sanitizing anything considered DEI-related

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